Clearance Summary
PLATELIA TOXO IGG KIT received FDA 510(k) clearance under submission number K894947, sponsored by Kallestad Diag, A Div. of Erbamont, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1990-03-23.
- Submission: K894947
- Applicant / Sponsor: Kallestad Diag, A Div. of Erbamont, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.7675
- Decision date: 1990-03-23
Classification & Regulation
This clearance is catalogued under FDA product code LGO and 21 CFR 864.7675, within the Hematology review panel as a Class I device.